The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis
ConditionMyasthenia Gravis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAd scientiam
About this trial
ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG.
ME\&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders.
The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME\&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.
Eligibility criteria
Qualifiers
Aged over 18 Years
Diagnosed with gMG at screening with generalized muscle weakness meeting the clinical criteria for diagnosis of MG, as defined by the MGFA Clinical Classification Class II, III, or IV, and likely not in need of a respirator for the duration of the study, as judged by the investigator
With positive serologic testing for anti-AChR autoantibody at screening
Have read the information sheet and signed the informed consent form
Disqualifiers
Subjects having undergone thymectomy Plasma Exchange Therapy or Intravenous Immunoglobulin Therapy within four weeks of screening
Subjects having initiated FcRn inhibitor therapy within the four weeks preceding screening
Known medical or psychological condition(s) or risk factor(s) that, as judged by the investigator, might interfere with the subject's full participation in the study, pose any additional risk for the subject, or confound the assessment of the subject or outcome of the study.
Pregnant and nursing women
Trial design
Treatments tested in this trial
- ME&MG mobile application
Treatment groups
144 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov